Regulatory Decision Summary for OCTAGAM 10%
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
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What was the purpose of this submission?
The submission requested consolidation of current marketing approvals for Octagam 5% and Octagam 10% solutions and approval for additional indications.
Octagam 10% was already indicated for Immune Thrombocytopenic Purpura (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count.
The following indications were added:
Replacement Therapy for Primary Immunodeficiency (PID) Syndromes including but not limited to:
- Congenital agammaglobulinaemia and hypogammaglobulinaemia;
- Common variable immunodeficiency; and
- Severe combined immunodeficiencies.
Secondary Immunodeficiency Syndromes including but not limited to:
- Secondary hypo-gammaglobulinaemia in patients with chronic lymphocytic leukaemia (CLL), or multiple myeloma (MM) with recurrent infections; and
- Children with congenital acquired immune deficiency syndrome (AIDS) who have bacterial infections.
Immune Modulation for Neurological Conditions
- Moderate to severe cases of Guillain-Barré Syndrome (GBS) in adults.
Why was the decision issued?
The product was approved for the indications Primary/Secondary Immune Deficiency and Immune Thrombocytopenic Purpura on the basis of previous approval of Octagam 5% for these indications. No new data were submitted in support of these indications since the biochemical characteristics of both preparations so far as the immunoglobulins are concerned are identical and extrapolation of efficacy from the 5% to the 10% strength is appropriate.
The indication for Guillain-Barre Syndrome was granted on the basis of a published meta-analysis given the difficulty of conducting controlled studies in this rare condition.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations